Temperature-controlled container with heating means and eutectic pack

ABSTRACT

A temperature-controlled container for transporting biologic tissue and human skin is set out wherein an outer insulated container houses a power source, a thermostat means, a heating means, a power source and interior container along with a retention means for holding the sample in place and a lid that interlocks with the open elongated chamber area by a T-shaped friction plug. The thermostat means may be a microchip and heating element so that the sample and interior temperature does not vary from a given temperature parameter. A eutectic pack which is a solid at room temperature and experiences a phase change to the liquid state at temperatures exceeding room temperature is provided to insure that a minimal super-ambient temperature is maintained.

FIELD OF THE INVENTION

The present invention generally relates to shipping containers, and morespecifically to temperature controlled containers for shipping biologicand other temperature-sensitive materials where a heating element toinfluence interior temperature is strategically interposed.

BACKGROUND AND SUMMARY OF THE INVENTION

As medical techniques, biologic materials and pharmaceuticalpreparations have become more sophisticated, numerous problems inherentin their being shipped arises. One such problem area relates to theshipment and preservation of human tissue or human organs and morespecifically human skin. When attempting to transport living tissue andspecifically human skin, the contents of the shipment must be maintainedwithin a narrow temperature range, which is preferably from about 92° F.to 104° F. Notwithstanding the restrictive temperature window, there aremany problems inherent in shipping human skin. Human skin is a fragilestructure, being labile to vibratory and mechanical damage. Shipping ortransporting human skin, also requires that the skin specimen itselfresides submerged in a liquid, nutrient-rich broth. In this conditionthe tissue sample continues to feed and maintain its viability. Failureto maintain the temperature range without exception results in loss ofthe tissue sample. For the burn patient or any patient undergoing askin-graft operation, the patient may lose his/her opportunity forundergoing a life-saving procedure.

Therefore, there has been a recognized longstanding need for furnishinga temperature-controlled container for shipping human tissue. Thecontainer must enable the manufacturer, shipper, warehouseman andend-user to ensure the safe delivery of the skin or tissue product. Fromindustry experience, it has been further recognized that human tissuematerials retained within such a container must not only be maintainedat very specific temperatures but also free from shock and vibration. Itshould be noted that the prior art presents a multitude of cryogenicallymaintained transport and storage containers.

The prior art presents a diverse array of temperature-maintainedcontainers. Containers in accordance with the prior art run the gamutfrom what amounts to an insulated pizza delivery box, on the one hand,to a sophisticated temperature-controlled container the size of a"steamer" trunk on the other. Obviously, such designs fall outside ofdimensional and weight parameters necessary for shipping throughaccepted channels. Overnight and courier delivery services are notreadily equipped to deliver oversized containers or containers thatrequire special power needs.

The main problem heretofore remaining unsolved, appertains to acontainer that maintains a desired temperature range while remainingmaneuverable, low in cost, dimensionally acceptable to transport andlater storage, and without the need for supervision or interventionduring shipping. The desired container must be temperature controllableand provide a specific interior temperature for a prescribed number ofhours. Being temperature-controlled is one quality, but being shockresistant is essential.

Given the facility that the medical profession has for being able toutilize human tissues and organs, it is now desirable to increase theamount of time between, transport, storage and use of the biologicmaterials. Therefore, it is highly desirable to provide atemperature-controlled container that will allow the user to store,transport and ultimately use the material over a period of time whichcan be measured in terms of days as opposed to minutes and hours. Thus,the need for intricate hand delivery and human failure is minimized byallowing for the tissue to be shipped over longer distances and timeperiods.

U.S. Pat. No. 4,723,974 issued to Ammerman discloses a container fortransporting an amputated extremity by utilizing a flexible walled innercontainer mounted inside of a flexible walled outer container. The spacewithin the outer and inner walls of the outer and inner containers isfilled with a chemical that, when activated, causes a significantreduction in temperature of the environment located within the innercontainer. The amputated part is maintained in a saline solution andcovers the same. It is disclosed that the amputated sample appendage isto be maintained at a sub-ambient temperature.

U.S. Pat. No. 5,040,678 issued to Lenmark discloses a container fortransporting biologicals where there is essentially a box within a boxconstruction. A block adds to the shock absorbing qualities.

U.S. Pat. No. 4,145,895 issued to Hjerstraud et al discloses a boxwithin a box design wherein a coolant material like deuterium oxide,undecyl cyanide, 4-bromo-decanoic acid and 2 bromo-decanoic acid is usedto maintain the contents in a sub-ambient or cold condition.

U.S. Pat. No. 4,630,448 issued to Blistad discloses a wide-mouthedflexible, collapsible, sterile bag made of sheeting of poly(ethylenevinyl acetate) for storing and shipping solid living tissue at very lowtemperatures. The thrust of the disclosure resides in maintaining thesterile bag flexible and intact at cryogenic temperatures.

U.S. Pat. No. 4,530,816 issued to Hamilton discloses a method and devicefor shipping biologic materials within a preferred temperature range offrom 4° C. to 10° C., that is near but above freezing. The sample mustnot be exposed to a temperature of less than 0° C. An isothermal cup orDewars Flask retains the sample and gelatinized ice retained in a metalcontainer provides the cooling media.

U.S. Pat. No. 4,502,295 issued to Pereyra discloses a storage unit formaintaining organs in a hypothermic environment, within a temperaturerange of from 0° C. to 7° C., by utilizing a series of containers withincontainers. The most important feature is the sub-ambient conditionwithin which the sample is maintained. An inner container provides areceptacle for ice thereby maintaining a cold environment.

U.S. Pat. No. 4,958,506 issued to Gulham discloses a container fortransporting grafts wherein a constant temperature equal to +4° C. ismaintained for 10 hours given an ambient temperature which is "normal."The system uses a thermal exchanger that is charged with a gas likebutane.

U.S. Pat. No. 4,986,076 issued to Kirk et al discloses the method ofusing an endothermic salt to maintain low temperature environment.

Notwithstanding the foregoing art that teaches low temperaturemaintenance, there is a recognized longstanding need for a container totransport biological materials at elevated temperatures. It should benoted that a container capable of such super-ambient parameters, whilealso being shock resistant and amenable to shipping through normalshipping channels is not described in the art. In addition, whilevarious forms of container-heaters have been tried, there has been noeffective means of using a heater to provide continuous interiorcontainer temperatures within a few degrees of tolerance whilemaintaining physical and cost parameters.

Therefore, the principal object of the present is to provide atemperature controlled container for transporting human tissue at aspecific temperature range.

Another object of the present invention is to provide a temperaturecontrolled container where the interior temperature may be maintained ata super ambient level of from 60° F. to 110° F. for at least 120 hours.

A further object of the present invention is to employ a sensitiveheating, and thermostat means to influence the interior containertemperature to thereby maintain a constant inner temperature at adesired temperature within four degrees from a set temperature.

Yet another object of the present invention is to provide an insulatedtemperature-controlled container capable of retaining a fragile sampleand frangible container in an undamaged condition.

Another object of the present invention is to provide a heating means tomodify and maintain interior container temperature in a less coldcondition.

A central object of the present invention is to provide a eutectic packto act as a heat sink in absorbing heat energy to assist in maintainingthe contents of the container within a desired temperature range.

Another object of the present invention is to provide a eutectic packthat may be preheated to release heat energy or act as a heat absorbingheat sink in the unheated condition.

The instant invention provides a container adapted to retain a biologicsample like human tissue, and more specifically human skin at a desiredtemperature range of from 92° F. to 104° F. for a period of at least 120hours. To implement this end, an outer insulated container is providedwith upstanding insulated walls, an insulated base and an insulated lidwhich nest by means of a friction plug and T-joint within the uppermostboundary of the elongated chamber created by the upstanding wall andbase. A power source is disposed within a recessed power sourceretention area. From the power source, and through leads the power istransmitted to a thermostat means and to a heating means. The heatingmeans is in intimate communication with an interior sample container.Disposed above the sample container resides a eutectic pack adapted toassist in maintaining the sample at an elevated or critical temperature.

The heating means is preferably in communication with the inner samplecontainer, operates on a low voltage power source sufficient to activatea heating means and is thermostatically controlled so that a specifictemperature range (92° F. to 104° F.) is maintained. An outer containeris adapted to receive the inner sample container, the outer containerbeing adapted to provide excellent insulation from outside temperaturesand prevent mechanical damage to the interior sample container.

The present invention provides an outer insulated container with aninsulated wall and insulated bottom creating an inner elongated chamber.An insulated lid means interlocks and reversibly seals the outercontainer. In the elongated chamber created as the inner area of theouter container an area is provided to retain a power source. The powersource is in communication with, and supplies a thermostat means and aheating means. The heating means is preferredly further comprised of aheating means, the heating means being retained in a matrix to presentthe same in a radial array and is reversibly affixed to an innercontainer which retains the skin sample. The heating means is actuatedby an on/off switch or by completing the connection with the powersource. When activated the heating element provides warmth to the innercontainer which retains the biologic or skin sample and to the innerelongated chamber. A series of isolating shock absorbing means may be incommunication with at least the four comers of a common shippingcorrugated container and the corresponding corners of the outercontainer.

The thermostat which may be a microchip, solid state device ormechanical means provides power and therefore heat when it senses thatthe sample or the surrounding ambient temperature falls belowpre-determined levels. The thermostat and heating means provide the userwith the ability to maintain super and sub-ambient temperatures and maybe used to make chamber temperature less cold or more warm depending onthe desired temperature range.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, incorporated in and forming a part of thespecification, illustrate several aspects of the invention, and togetherwith the description serve to explain the principles of the inventionwherein:

FIG. 1 is a perspective drawing taken as a partial cutaway showing thetemperature controlled container with heating means;

FIG. 2 is an elevational view taken in cross-section showing thetemperature-controlled container with heating means in closed condition;

FIG. 3 is a top plan view of the heating means;

FIG. 4 is a schematic view of the thermostat means;

FIG. 5 is a perspective drawing taken as a partial cutaway showing theheating means and power source; and

FIG. 6 is an elevational view taken in cross section showingtemperature-controlled container with heating means in a closedcondition disposed within a corrugated shipping container with shockabsorbers disposed therein.

DETAILED DESCRIPTION

Referring with more specificity to the drawings where like numeralsrefer to like parts temperature-controlled container with heating meansthroughout, FIG. 1 shows a temperature-controlled container with heatingmeans 10 for transporting materials at pre-set temperatures relative toexterior temperatures.

As shown in FIG. 2, temperature controlled container with heating means10 incorporates an outer container 12 and a lid means 22. In a preferredembodiment, outer container 12 is insulated and for purposes of exampleshall be termed insulated outer container 12, possesses upstandinginsulated wall 14 and an insulated bottom 16. The union of insulatedwall 14 and insulated bottom 16 gives rise to inner elongated chamber 48defined by inner wall surface 20 of insulated wall 14 and 18 ofinsulated bottom 16.

As depicted in FIG. 1, it is preferred that upstanding insulated wall 14is comprised of a plurality of upstanding walls sufficient to form abox-shaped enclosure. By modifying the number of walls, changes ingeometric shape results from one upstanding wall as in a circularconstruction to a multi-sided polygon. For purposes of the presentinvention, four upstanding walls create an overall rectilinear-shapedcontainer. While outer container 12 may be constructed from anymaterial, a light structurally sound and insulating material ispreferred. Therefore, it is preferred that outer container 12 befashioned from a closed cell polymer. The preferred polymers areurethane and expanded polystyrene. The insulating factors for theresulting wall should have R factor based on a two pound density ofexpand polystyrene which is one inch thick has a K factor for the samewhich is about 0.23 at 75° F.

As shown in FIGS. 1 and 2, annular chamber 48 defined by inner wallsurface 20 of insulated wall 14 and 18, of insulated bottom 16, andprovides a discreet area to retain a heating means 26 which includesheating assembly 30, a thermostat and sensing means 32, a power source28, and inner sample container 46 retaining a temperature sensitivematerial. Elongated chamber 48 is defined by inner wall surface 20 ofinsulated wall 14 and 18, of insulated bottom 16, and is approximatelyseven inches in width, while insulated wall 14 is approximately 2 inchesin width. When using expanded polystyrene the 1 to 3.5 ratio of outerwall to inner elongated chamber appears to be operatively preferred. Thewall thickness of 2 inches could be reduced with a more efficientpolymer or insulating material, although the 2-inch thickness of thewall heightens the overall vibration and shock resistant qualities ofthe temperature-controlled container with heating means 10.

As most clearly set out in FIG. 2 recessed within insulated bottom 16and preferably integral therewith is a shallow excavated or recessedretention chamber 34 adapted to receive power source 28. Power source 28is preferably a battery pack, as for example a series of standard cells,which may be rechargeable. By example in the present invention four C, Dcells may be used and dimensionally accommodated. Retention chamber 34,which is preferably fashioned as part of the closed cell bottom 16insulates power source 28. With power source 28 residing within arecessed cutout the batteries are protected from sub-ambienttemperatures while the open top contributes to heating of chamber asheat rises from the batteries. This dynamics is especially advantageouswhen temperature controlled container 10 is shipped under lowtemperature conditions. Retention chamber 34 uses the inherent heat fromthe discharge of power source 28 to maintain a heated atmosphere so thatpower source 28 will continue to function. Excess heat will dissipateinto elongated chamber 48 and beneficially assist in maintaining superambient temperature conditions.

In accordance with FIG. 1, upstanding wall 14 is in furthercommunication with upstanding walls 14a, 14b, and 14c. While the outerwall surface of upstanding walls 14, 14a, 14b and 14c is flat a planareach corner where said upstanding walls 14, 14a, 14b and 14c meet oneanother are, in a preferred embodiment, radiused so that radius edge 50adds an overall oblong character to the otherwise square appearance. Byusing radius edge 50 a significant amount of weight may be reducedwithout affecting the insulation factors. A second advantage obtains tothe ease of extracting filled temperature-controlled container withheating means 10 from a shipping container like a corrugated box.

As best depicted in FIGS. 1 and 2, constructed from the same closed cellpolymeric compound as outer container 12. By milling or molding the lid,depending interlocking lip 24 and upper surface interlocks and fits withthe upper area of inner elongated chamber 48 creating a T-shapedfriction plug-type joint between lid 22 and outer container 12. FIG. 2more clearly illustrates the T-shaped friction plug-type joint. Overall,the conformation may further be described as being counter-sunk andinterlocking.

As illustrated by FIG. 5 heating means 26 is preferably powered by a lowvoltage power means. Power means 28 is preferred to produce from 2 voltsto 24 volts of electricity at 0.1 to 1.0 amperes. On/off means 75 whichmay be a switch or merely a plug connection, when actuated suppliespower to heating means 26. As a result of the drawing of power andresulting heating may be almost imperceptible at times, an "on"indicator light 70 like a light-emitting diode may be operativelyinterposed. In accordance with FIGS. 3,4 and 5 one preferred embodiment,heating means 26 includes, power source 28, heating assembly 30, athermostat and sensing means 32, lead means 38, heating element 36,on/off means 75, indicator light 70. Heating element 36 may be embeddedin a polymer matrix and is in communication with inner sample container46 as by being reversibly, adhesively affixed.

As described hereinabove, and illustrated by FIGS. 1,2 and 5 the powersource may be derived from easily obtainable batteries. For example, apreferred arrangement may include four D-size batteries or four C-sizebatteries while the indicator light 70 may be a light-emitting diodewhich takes from 1 to 10 volts to operate. In the present invention, aseries of batteries sufficient to comprise 12 ohms and 6 volts willprovide sufficient power for a direct current heater and the thermostatchip set out hereinbelow.

FIGS. 3 and 4 show that heating means 26 may be further comprised of apolymer circuit board and a thermostat means. Thermostat means 40 ofFIG. 4, may be a bi-metallic strip, a solid state device or microchip. Amicro-chip like the model DS1821 thermostat chip (manufactured by DallasSemi-Conductor Company of Dallas, Tex.) is typical of the microchip orsolid state device which may be operatively substituted. Thermostatmeans 32 should be able to continually sense the surrounding temperatureand if positioned in close association inner sample container 46 closelyapproximates the actual temperatures endured by the sample retainedwithin inner sample container 46. Inner container 46 constructed fromglass or a rigid polystyrene or polyvinyl chloride sufficient tomaintain its integrity may retain the human skin and rests within outercontainer 12.

As shown in FIG. 2, a stop means 54 is interposed to prevent innersample container 46 from dislodging and moving with a force sufficientto damage the tissue or other sample retained therein. It is preferredthat an open cell polymer be interposed, said polymer presenting aspongy quality so that it will deform under stress and absorb vibratoryenergy and shock. Other materials like urethane packing peanuts orbubble wrap can be operatively substituted.

It should be noted that the construction in accordance with the presentinvention, unlike what has come before, provides constant monitoring ofthe sample so that immediate compensatory action may be taken inresponse to changes in temperature. When sample temperature changesmarkedly, thermostat means 32 completes the circuit which activatesheating through heating element 36. It is preferred that heating element36 is constructed from resistance wire encased in a polymer matrix is incommunication with the bottom surface of the inner container to impartadditional heat energy when required so that a constant temperature maybe maintained. Power source 28 provides energy to heating element 36,the power source being preferably a battery of from 2 volts to 24 volts,and the current passing through the resistance wire generates heatsufficient to influence the temperature within inner elongated chamber48.

In accordance with FIG. 6, power source 28 is connected to heater means26 via leads 38. Therefore, in accordance with FIGS. 3,4 and 5, powersource 28 through leads 38 supply current to circuit board 40, throughlegs 44a-44c. Circuit board 40 is preferably of from 0.03 to 0.06 inchesthick and preferably. Heater means 26 also contains an on/off switch 75,a light means 70 and a thermostat means 32. With one lead going tothermostat means 32 and the other to heating element 36 of heating meansa circuit is either closed or left open as a sensor means 42 inthermostat means 32 discerns temperatures either outside or within thepreset temperature range.

A variety of different polymers may be used for the outer container. Itis preferred that the polymers which may be "foamed" to provide a closedcell structure that can be further expanded by entraining. Expandedpolymers are given to include a closed cell structure where a gasenlarges the structure by being entrapped therein. The resulting closedcell foams are rigid and possess a thermal conductivity which issomewhat higher than the entrapped gas. A preferred gas for purposes ofthe present invention is air although hydrogen, oxygen, nitrogen, watervapor, hydrocarbons (ie pentane, methane etc) and fluorocarbons may beoperatively substituted. A preferred polymer is expanded polystyrene,but polyurethane, polyvinyl chloride, polycarbonates, polyisocyanates,certain phenolics, sulfones, and polyesters are capable of creating aclosed cell structure are suitable. Expanded polystyrene is preferreddue to its benign environmental aspects, mechanical strength andinsulation qualities.

It has been found that by using a radius-type edge significant weightsavings can be achieved without a loss in insulating factors. When usinga two pound density expanded polystyrene for outer container 12 having awall thickness of about two inches a radius may be cut on each of thefour corners so that a weight savings of about 5% to about 10% may beachieved. As depicted in FIG. 6, the radiused edge 50 adds furtherclearance at the corners to prevent contact with the surfaces ofcorrugated outer container 12 if there is an instance of jarring andshock.

Inner container 46 which holds a human skin sample is further fashionedfrom a hard polymer or glass material to retain a piece of human skin ina nutrient-rich broth. Inner container 46 is not only non-porous but inmany instances frangible, as in the case of a glass container, like aPetri dish. While inner container 46 may be of many sizes, innerelongated chamber 48 would be reduced concomitant therewith.Accommodating inner container 46 which retains, human skin maintained at92° F.-104° F. and immersed in an aqueous bath of saline and nutrients(so that the skin may continue to feed and remain viable) is unique tothe design in accordance herewith.

As set out in FIG. 2, retention means 54 lessens the likelihood of innercontainer 46 suffering mechanical damage from vibration, shock andimpact during shipping. Retention means 54 may be constructed from anopen cell polymer. The open cell structure unlike the closed cellstructure of the wall means 12 has only some rigidity, and thereforegreat deformation qualities and makes an ideal cushion. A preferredretention means is an open cell foam block, but other retention meansare "Styrofoam" peanuts and bubble wrap. A flexible open cell foam suchas polyurethane may be operatively substituted.

As best depicted in FIG. 6 a corrugated box 80 which is, drawn but notclaimed as part of the instant invention, removably acceptstemperature-controlled container with heating means 10 and isolatingshock absorbers 58. Shock absorbers 58 abut each corner of radius edge50 and are retained therein by the mechanical pressure exerted by thememory of the deformed material. It is preferred that an open-cellpolymer be used since its flexibility, compressibility, heightened shockabsorbency, economic price, ease of manufacture, and light weight makeit an ideal material. The most preferred material is a polyurethane orpolyvinylchloride open cell flexible foam material. The pore size variesin accordance with material and method of manufacture, although a spongydeformable consistency is preferred.

In accordance with FIG. 6 there would be a total of ten polyurethaneshock absorbers, four in each of the bottom comers, four in each topcorner, one in the center of the bottom area and one directly below theflaps of the top area. A corrugated container would enshroudtemperature-controlled container with heating means 10 and retain thesame during shipping and storage.

Perhaps one of the most advantageous uses for temperature-controlledcontainer and heating means 10 appertains to keeping varioustemperature-labile materials cold but safeguarding the same fromfreezing or enduring temperatures that are at or near freezing. In thisinstance heating means 26 may be used as a temperature moderating meansto prevent the inner temperature of elongated chamber 48 from droppingbelow specified temperatures. Hence, heating means 26 may keep theinterior of temperature-controlled container and heating means 10 in aless cold condition. The container in accordance with present inventionis specially suited for maintaining temperatures within an overalltemperature range of from about 60° F. to 110° F. when the ambienttemperature is about room temperature.

In accordance with FIGS. 1 and 2 eutectic pack 56 is preferablypositioned above inner sample container 46 and in close associationtherewith. Eutectic pack 56 as best shown in FIG. 1 further incorporatesan impermeable polymer skin surrounding a core preferably comprisedof--49% calcium chloride hexahydrate, (CACL2.6H2O) 1%carboxymethylcellulose and the remaining 50% water. This combination isa solid at room temperature with its phase change beginning at about 30degrees Centigrade. Eutectic pack 56 is an extremely efficient heatsink, absorbing great amounts of heat energy when it is below its phasechange temperature. Eutectic pack 56, in its change of phase from solidto liquid, can absorb a great amount of heat energy. Conversely, ifpre-heated eutectic pack 56 can provide a significant source for therelease of heat energy. Eutectic pack 56 as in the present invention mayconsist of a 3/4 pound 5 inch square polymer package containing calciumchloride hexahydrate, carboxymethylcellulose and water mixture, which isessentially a solid at room temperature, the pack being aboutone-quarter inch in thickness.

The foregoing description of a preferred embodiment of the presentinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or limit the inventionto the precise form disclosed. Obvious modifications or variations arepossible in light of the above teachings. The embodiments were chosenand described to provide the best illustrations of the principles of theinvention and its practical application to thereby enable one skilled inthe art to utilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated. All suchmodifications and variations within the scope of the invention asdetermined by the appended claims when interpreted in accordance withthe breadth to which they are fairly, legally and equitably entitled.

We claim:
 1. A temperature-controlled container with heating meanscomprising:a. an outer container creating an inner chamber; b. an innerretention chamber retaining a power source and a sample container; c. athermostat means in communication with a power source and an on/offmeans to restrict or provide power from said power source; d. a heatingmeans, said heating means in operative communication with said samplecontainer, and said heating means being removably affixed to said samplecontainer; and e. a eutectic pack.
 2. The temperature-controlledcontainer with heating means in accordance with claim 1 wherein saidouter container further comprises:a. at least an upstanding insulatedwall; b. an insulated bottom in communication with said insulated wallforming an inner elongated chamber; and c. an insulated lid means. 3.The temperature-controlled container with heating means in accordancewith claim 2 wherein said at least an upstanding wall has a plurality ofupstanding walls.
 4. The temperature-controlled container with heatingmeans in accordance with claim 3 wherein said plurality of upstandingwalls has radiused edges.
 5. The temperature-controlled container withheating means in accordance with claim 2 wherein said insulated lidmeans and said upstanding wall means cooperates to form an interlockingT-shaped friction joint.
 6. The temperature-controlled container withheating means, in accordance with claim 1 wherein said outer containeris further comprised of a closed cell polymeric material.
 7. Thetemperature-controlled container with heating means, in accordance withclaim 6 wherein said closed cell polymeric material is expandedpolystyrene.
 8. The temperature-controlled container with heating meansin accordance with claim 7 wherein said closed cell polymeric materialis expanded polystyrene having a density of about 2 pounds per cubicfoot.
 9. The temperature-controlled container with heating means inaccordance with claim 1 wherein said power source is at least onebattery.
 10. The temperature-controlled container with heating means inaccordance with claim 1 wherein said heating means is a heating elementof resistance wire in a polymer matrix.
 11. The temperature-controlledcontainer with heating means in accordance with claim 2 is adapted to beremovably affixed to a sample container.
 12. The temperature-controlledcontainer with heating means in accordance with claim 1 wherein thethermostat is comprised of a solid state device adapted to insure that aconstant temperature is preserved.
 13. The temperature-controlledcontainer with heating means in accordance with claim 12 wherein saidthermostat is disposed within the heating coil.
 14. Thetemperature-controlled container with heating means in accordance withclaim 12 wherein said thermostat is comprised of a micro-chip.
 15. Thetemperature-controlled container with heating means in accordance withclaim 11 wherein said thermostat is comprised of a bi-metallic strip.16. A heating means in accordance with claim 1 comprising:a. a powersource; b. a switch means controlling the power source; c. a thermostatmeans and a heater with a heating element and polymer matrix.
 17. Aheating means in accordance with claim 16 further comprising saidthermostat means located centrally within said heater.
 18. A heatingmeans in accordance with claim 17 further comprising said matrix with aseries of heating elements being from 0.001 inches to 0.020 inches inthickness.
 19. A heating means in accordance with claim 16 furthercomprising said matrix being further comprised of a thermoplasticpolymer.
 20. A heating means in accordance with claim 16 furthercomprising said matrix being further comprised of a metalized polymersheet.
 21. A thermostat means in accordance with claim 1 furthercomprising:a. a power source; b. a lead means from said power source toa heating element, said heating element being retained in a polymermatrix; and c. a second lead means in operative communication with athermostat means, said thermostat means sensing the temperature ambientthereto and providing power upon the sensing of a specific temperaturefrom said power source to said heating element.
 22. Thetemperature-controlled container with heating means in accordance withclaim 1 where a retention chamber retains the power source.
 23. Thetemperature-controlled container with heating means in accordance withclaim 1 adapted to be received in a shipping container.
 24. Thetemperature-controlled container with heating means in accordance withclaim 23 where an isolated shock absorbing means is in communicationwith each corner of said temperature-controlled container with heatingmeans.
 25. An isolated shock absorbing means in accordance with claim 23wherein said isolated shock absorbing means is fashioned from an opencell polymeric foam.
 26. The eutectic pack in accordance with claim 1further comprised of calcium chloride hexahydrate,carboxymethylcellulose and water.
 27. The eutectic pack in accordancewith claim 1 further comprised of 49% calcium chloride hexahydrate, 1%carboxymethylcellulose and 50% water.